1. Sexually active, fertile males must use effective birth control if their partners are women of childbearing potential. Adequate birth control methods for both males and females (as appropriate) are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable or patch hormonal contraception, oral contraceptives, an IUD, double-barrier contraception, or true sexual abstinence. The form of birth control for the male and/or partner, where relevant, must be documented at screening and baseline.